1-Week Dispensing Evaluation of REVIVE™ Toric Soft Contact Lenses

Last updated: January 2, 2024
Sponsor: Bausch & Lomb Incorporated
Overall Status: Completed

Phase

N/A

Condition

Eye Disorders/infections

Eye Disease

Astigmatism

Treatment

REVIVE Contact Lens

Clinical Study ID

NCT06053736
ROC2-23-008
  • Ages > 18
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

Experienced soft contact lens wearing subjects will be enrolled in this 1-week, post-market, bilateral, repeated measures, dispensing study. All subjects will be seen for a Screening/Dispensing Visit at which informed consent will be obtained and eligibility will be assessed. If subjects satisfy all eligibility criteria and none of the exclusion criteria, subjects will be fit and dispensed study lenses. If unsuccessful in the dispensed lenses, additional lenses may be trialed. Once vision and lens fit are determined to be acceptable, eligible subjects will wear study lenses in both eyes for at least 8 hours per day (with the exception of the follow-up visits where the lenses should be worn for a minimum of 2 hours), for approximately 1 week (7 days +/-3 days). Measurements will be taken at the insertion visit and at the 7-day follow-up visit.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Be 18 years or older on the date the Informed Consent Form (ICF) is signed and havecapacity to read, understand and provide written voluntary informed consent.
  2. Have physiologically normal anterior segments not exhibiting clinically significantbiomicroscopy findings.
  3. Have no active ocular disease or allergic conjunctivitis.
  4. Not be using any topical ocular medications.
  5. Be willing and able to follow instructions.
  6. Have signed a statement of informed consent

Exclusion

Exclusion Criteria:

  1. Participating in a conflicting study in the opinion of the Investigator.
  2. Considered by the Investigator to not be a suitable candidate for participation.

Study Design

Total Participants: 26
Treatment Group(s): 1
Primary Treatment: REVIVE Contact Lens
Phase:
Study Start date:
October 04, 2023
Estimated Completion Date:
December 15, 2023

Connect with a study center

  • Bausch & Lomb, Incorporated

    Rochester, New York 14609
    United States

    Site Not Available

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